A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Evaluation of the Efficacy and Safety of DEX-IN Following Painful Outpatient Procedures

REC-17-023

The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.

2017-11-15

2018-01-18

2018-01-18

Completed

Early phase I

45

Inclusion Criteria: * Voluntarily provide written informed consent * Be planned to undergo a selected office-based or outpatient procedure * Be naïve to the planned procedure, i.e. no repeated or revision procedures * Not pregnant or planning to become pregnant, or using appropriate contraceptive measures. Exclusion Criteria: * Known allergy to any study treatment or excipient * Have another painful physical condition or anxiety related diagnosis that may confound study assessments * Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG * Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double-blind, double-dummy', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}

2023-05-25